| NDC Code | 17856-0087-2 |
|---|
| Package Description | 1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0087-2) > 5 BOX, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-3) > 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-1) > 5 mL in 1 CUP, UNIT-DOSE |
|---|
| Product NDC | 17856-0087 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydrocodone Polistirex And Chlorpheniramine Polistirex |
|---|
| Proprietary Name Suffix | Extended-release |
|---|
| Non-Proprietary Name | Hydrocodone Polistirex And Chlorpheniramine Polistirex |
|---|
| Dosage Form | SUSPENSION, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20150306 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA091632 |
|---|
| Manufacturer | ATLANTIC BIOLOGICALS CORP. |
|---|
| Substance Name | CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE |
|---|
| Strength | 8; 10 |
|---|
| Strength Unit | mg/5mL; mg/5mL |
|---|
| Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA] |
|---|
| DEA Schedule | CII |
|---|